172 days ago on axepta.ch

International QA Manager MES Project

AXEPTA SA

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 Please refer to JobSuchmaschine in your application

International QA Manager MES Project

International QA Manager MES Project

My client is an established and renown international pharmaceutical company currently expending their team due to a new challenging project in the canton of Vaud, Switzerland.

 

Due to this new project, my client is looking for an International QA Manager with strong operational and GMP experience.

 

Responsibilities:

 

You will provide the global Quality Assurance support for the Manufacturing Execution System project especially for the deployment aspect.

 

  • Quality process mapping:
  • Ensure the building and delivery of a quality process mapping for each manufacturing area (weighing, compounding, filling & packaging) in scope for the ManufacturingExecution System Project, including: interviews with operators and super users, process mapping through material flows, people flows, and documents flows, documentation review for the Standard Operating Procedure, Master Batch record, Batch documentation, deviations notably

 

  • Improvement and action plan at site level:
  • Identify quality and compliance gaps and good practices,
  • Perform the quality risk assessment,
  • Define and deploy the improvement required,
  • Model the good practices and integrate the improvements to the new Solution
  • Replicate tool kit for all manufacturing areas and lines.

 

  • Consolidation and standardization at global level:
  • Ensure identified practices in the new system fit globally for the Manufacturing division, and standardize for the entire company’s plant.

 

Your Profile:

  • You have a university Degree at Master or Engineer level in scientific field (Chemistry, Pharmacy, Biology) or related health science,
  • At least 5 years of professional experience in a pharmaceutical plant in similar positions Operational Quality Assurance, Quality Management working on Master batch record, batch review, recipe creation and review notably. A good experience in international and multidisciplinary environments is required,
  • Strong knowledge of relevant regulatory requirements (FDA, EU GMP, ANVISA, ISO 13485, ISO 22716…),
  • Operational knowledge and experience with software applications in a GxP environment,
  • Strong knowledge of quality management and CSV (GxPs, 21CFR Part 11, Annex 11, GAMP) aspects of computer system applications,
  • Experience with ManufacturingExecution System (MES software) is an asset,
  • Results driven and quality focus, innovative mindset and pragmatic solutions to solve problems
  • Ability to travel up to 25% of the time
  • You are fluent in English (oral and written) – other languages would be an asset.

 

For more information please send your full CV at mailto: noliva@axepta.com